BEUDAMED
    FDA Adverse Event Other Summary report: N

    REUSABLE MONOPOLAR FORCEPS

    MDR report key: 1823471 · Received August 25, 2010

    Report

    Report Number
    1530493-2010-00006
    Event Type
    Other
    Date Received
    August 25, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 18, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS SENT TO OLSEN MEDICAL AND RECEIVED ON 08/04/2010. THE RISK ANALYST DID NOT KNOW THE LOT NUMBER AS REPORTED THERE WAS NONE VISIBLE. SHE ALSO STATED, THE FORCEPS WERE PRINTED WITH, "RAINEY BOVEY". OLSEN MEDICAL DOES NOT AND HAS NEVER PRINTED, "RAINEY BOVEY ON ANY FORCEPS. SPIKE WITH THE DEPARTMENT MANAGER ON (B)(4) 2010 AND HE STATED, WE SHOULD BE ABLE TO GET THE DEVICE BACK. HE WAS PROVIDED WITH AN RMA NUMBER, BUT THE DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A PATIENT INADVERTENTLY RECEIVED A BURN FROM THE BOVIE TO THE RIGHT BUCCAL MUCOSA SECONDARY TO A BREAK IN THE INSULATION OF THE MONOPOLAR BOVIE. THE BURN WAS SUPERFICIAL AND NOTED AS MINOR. THE PATIENT WAS HAVING A TONSILLECTOMY AND THE PATIENT'S TEETH MAY HAVE CONTRIBUTED TO THE INSULATION BREAKDOWN. IT IS UNKNOWN IF THE INSULATION WAS INTACT PRIOR TO ITS USE. (AS REPORTED FROM THE INITIAL REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE MONOPOLAR FORCEPS REUSABLE MONOPOLAR FORCEPS GEI OLSEN MEDICAL 41501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other